Regulatory Affairs CMC Senior Manager

Vor 2 Tagen

Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

About the Role

Gilead Sciences Switzerland Sarl is seeking a highly motivated and experienced regulatory affairs professional to join our team as a CMC Regulatory Affairs Senior Manager. In this role, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business goals.

Key Responsibilities

  • Develop and implement CMC regulatory strategies to support product launches and label expansions.
  • Prepare and submit CMC components of regulatory submissions, including marketing authorization and post-approval submissions.
  • Collaborate with cross-functional teams to ensure consistency and accuracy of regulatory documents.
  • Provide regulatory intelligence and guidance to teams on CMC registration requirements and best practices.
  • Ensure adherence to regulatory requirements and internal procedures.
  • Communicate effectively with stakeholders on regulatory matters.

Requirements

  • Scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities.
  • Fluent in written and spoken English and German, with knowledge of Hebrew an asset.
  • Practical knowledge of ICH and EU and/or Swiss CMC regulatory requirements.
  • Experience with submission compilation and filing of regulatory submissions, including marketing authorization and technical variations.
  • Proven experience in regulatory affairs, with a focus on CMC regulatory activities.

About Gilead Sciences Switzerland Sarl

Gilead Sciences Switzerland Sarl is a leading biopharmaceutical company that develops and commercializes innovative medicines to treat life-threatening diseases. We are committed to making a difference in the lives of patients and to advancing the field of biopharmaceutical research.

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